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US11260249B2ActiveUtilityPatentIndex 50

System, apparatus and method for high intensity focused ultrasound and tissue healing activation

Assignee: SONACARE MEDICAL LLCPriority: Jul 19, 2018Filed: Jul 19, 2018Granted: Mar 1, 2022
Est. expiryJul 19, 2038(~12 yrs left)· nominal 20-yr term from priority
Inventors:CAROL MARK
C12N 5/068A61N 2007/025A61B 8/5207A61B 2090/3762A61B 8/42A61B 2017/00154A61B 8/4494A61N 7/02A61B 8/08A61B 2090/374A61B 34/25A61B 5/0036
50
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0
Cited by
70
References
11
Claims

Abstract

A method of treating colorectal cancer included placing a high intensity focused ultrasound (HIFU) probe proximate a designated treatment volume at one of the colon and the rectum of a patient. The method further includes delivering HIFU via the HIFU probe at a frequency of at least 1 mHz for at least 3 seconds to raise a temperature of a first portion of the designated treatment volume to above 65° C., thereby ablating the first portion and causing a tissue defect within the designated treatment volume. The method further includes applying a nonablative dose of energy via the HIFU probe to a second portion of the designated treatment volume to provoke stem cell homing in the second portion, thereby encouraging tissue regrowth.

Claims

exact text as granted — not AI-modified
I claim: 
     
       1. A method of treating cancer, the method comprising the steps of:
 a) placing a high intensity focused ultrasound (HIFU) probe including at least one transducer proximate a designated treatment volume of a patient, the designated treatment volume being a macroscopic three-dimensional volume and including at least a portion of an organ, the designated treatment volume being located beneath subcutaneous fat of the patient; 
 b) ablating a first portion of the designated treatment volume with energy emanating from the transducer of the HIFU probe using a first set of parameters designed to achieve ablation of the first portion, this step including delivering HIFU via the HIFU probe at a frequency of at least 1 MHz for at least 3 seconds to raise a temperature of the first portion of the designated treatment volume to above 65° C., the first portion being a three-dimensional volume having a width, a height, and a depth, the first portion being located entirely beneath the subcutaneous fat of the patient such that ultrasound waves pass from the transducer through the subcutaneous fat so as not to treat the subcutaneous fat and the ultrasound waves coalesce at the first portion, the first portion not encompassing or contacting the organ; 
 c) delivering a nonablative dose of energy to a second portion of the designated treatment volume with energy emanating from the HIFU probe using a second set of parameters designed to achieve such a nonlethal dose, this step including use of a frequency between 100 KHz—1 MHz delivered in bursts between 1-10 milliseconds at a time, the second portion being a three-dimensional volume having a width, a height, and a depth, the second portion being located entirely beneath the subcutaneous fat of the patient and entirely encompassing the first portion such that an entire outer periphery of the first portion is contained within the second portion, the second portion having a larger width, height, and depth than the first portion and extending laterally beyond the first portion, the second portion encompassing or contacting the organ, the energy from the nonablative dose passing from the transducer through the subcutaneous fat so as not to treat the subcutaneous fat and the energy from the nonablative dose coalescing at the second portion; and 
 d) injecting stem cells into the patient (i) after step b) and before step c), or (ii) after both step b) and step c), 
 wherein the application of the nonablative dose of energy to the second portion provokes stem cell homing at the second portion, and 
 wherein the provocation of stem cell homing encourages tissue regrowth to close one or more tissue defects. 
 
     
     
       2. The method of  claim 1 , wherein the probe is in a first position when the ablative energy is directed to the first portion, and wherein the probe is in the same first position during the application of the nonablative dose of energy to the second portion. 
     
     
       3. The method of  claim 1 , wherein the at least one transducer includes one or more ultrasound transducers configured to image and treat the designated treatment volume, the one or more ultrasound transducers including at least one first crystal optimized for pulsed focused ultrasound (pFUS) and at least one second crystal optimized for ablative focused ultrasound (aFUS), the at least one first crystal being located on a first side of the transducer and the at least one second crystal being located on an opposing second side of the transducer. 
     
     
       4. The method of  claim 3 , wherein the one or more ultrasound transducers are each single array transducers formed of a two parts, the two parts include at first crystal optimized for pFUS and a second crystal optimized for aFUS, and wherein the second crystal surrounds at least a portion of the first crystal. 
     
     
       5. The method of  claim 1 , further comprising:
 defining the first portion of the designated treatment volume prior to ablating the first portion; and 
 defining the second portion of the designated treatment volume prior to ablating the first potion. 
 
     
     
       6. The method of  claim 1 , wherein step c) is delivered simultaneously to the step of ablating the first portion of the designated treatment volume. 
     
     
       7. The method of  claim 6 , wherein prior to placing the HIFU probe proximate the designated treatment volume, the method comprises imaging the designated treatment volume using at least one of ultrasound, magnetic resonance imaging, computed tomography and positron emission tomography. 
     
     
       8. The method of  claim 7 , wherein step d) occurs before step c). 
     
     
       9. The method of  claim 1 , wherein the stem cells are exogenous stem cells. 
     
     
       10. The method of  claim 1 , wherein the organ is an esophagus, rectum, stomach, colon, small bowel, gall bladder, uterus, vagina, bladder, oral mucosa, breast, prostate, liver, or kidney. 
     
     
       11. The method of  claim 10 , prior to step a), inputting the type of cancer to be treated into one or more computing devices, the one or more computing devices then generating the first set of parameters and the second set of parameters.

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